2 Case: Document: Page: 2 Date Filed: 04/28/2014 TABLE OF CONTENTS PAGE TABLE OF AUTHORITIES... iii INTRODUCTION... 1 INTERESTS OF THE FEDERAL TRADE COMMISSION... 3 STATEMENT OF THE CASE Pharmaceutical Patents, Generic Entry and the Hatch-Waxman Amendments The Economics of Generic Entry and Reverse- Payment Agreements The Economics of a No-AG Commitment The Supreme Court s Decision in FTC v. Actavis and the Current Litigation SUMMARY OF ARGUMENT ARGUMENT I. ACTAVIS CONFIRMS THAT PATENT SETTLEMENTS BETWEEN A PATENTEE AND ITS POTENTIAL COMPETITOR ARE SUBJECT TO TRADITIONAL ANTITRUST PRINCIPLES II. A NO-AG COMMITMENT RAISES ALL THE SAME CONCERNS THAT THE ACTAVIS COURT IDENTIFIED AS A BASIS FOR ANTITRUST REVIEW III. RECIPROCAL AGREEMENTS NOT TO COMPETE CAN CAUSE ANTICOMPETITIVE HARM AND MAY VIOLATE THE ANTITRUST LAWS i

9 Case: Document: Page: 9 Date Filed: 04/28/2014 INTRODUCTION In FTC v. Actavis, 133 S. Ct (2013), the Supreme Court reaffirmed that traditional antitrust principles apply to patent settlements and that patent law confers no broad immunity on parties to such agreements. Applying that principle, the Court held that a brand-name drug manufacturer s payment in patent litigation to a potential generic entrant can violate the antitrust laws under the rule of reason. The Court contrasted such reverse payment cases with certain other patent settlements, including those in which the parties simply specify a date on which generic entry will be permitted. As the Court recognized, agreements in the latter category are normally unproblematic because they presumably reflect only the parties risk-adjusted views of likely litigation outcomes. Id. at But antitrust concerns do arise where a branded-drug company agrees to make a reverse payment to compensate a generic company for staying out of the market for some period, thereby eliminating the risk of competition and preserving while sharing the branded-drug company s monopoly profits. Originally, reverse payments often took the form of outright cash transfers. Today, after years of antitrust scrutiny, a branded-drug company may sometimes induce a generic company to stay out of the market by offering it payments in kind rather than in cash. This case exemplifies that phenomenon. -1-

10 Case: Document: Page: 10 Date Filed: 04/28/2014 The reverse payment alleged here took the form of a valuable contractual commitment. Teva Pharmaceuticals initially challenged a patent that purportedly covered the anti-epileptic drug Lamictal and sought to introduce a cheaper, generic version. Congress enacted the Hatch-Waxman Amendments of 1984 precisely to spark challenges of this sort. Such challenges, when successful, greatly reduce drug prices to the benefit of consumers. But Teva abandoned its challenge in favor of a settlement agreement with GlaxoSmithKline, LLC (GSK), the manufacturer of brand-name Lamictal. That agreement freed GSK from the uncertainties of a patent challenge and guaranteed that it would enjoy several more years of monopoly profits. GSK, in turn, agreed that, when Teva did finally introduce generic Lamictal tablets, GSK would refrain from introducing its own authorized generic (AG) product i.e., the brand-name drug, but marketed as a generic product. That No-AG commitment allowed Teva to capture all generic sales for six months and thus earn supracompetitive profits of its own. Thus, according to the complaint, the agreement denied consumers the opportunity to purchase generic Lamictal for several years and then, when a generic version finally became available, ensured that consumers would pay more for it than if the two companies had offered competing generic products. As alleged, the arrangement was a win-win for the parties, but a loss for consumers. -2-

11 Case: Document: Page: 11 Date Filed: 04/28/2014 The district court nonetheless dismissed this case. It distinguished Actavis on the ground that the branded-drug company there had compensated the generic company in cash to induce it to stay out of the market for a defined period, whereas the branded-drug company here extended compensation in the form of a valuable agreement not to compete. The Actavis decision does not distinguish among the many forms of compensation that can support a potentially problematic reversepayment settlement. If accepted, the district court s narrow reading of Actavis would undermine the Supreme Court s decision in that case and encourage parties to structure potentially anticompetitive reverse-payment settlements simply by avoiding the use of cash. This Court should reverse. INTERESTS OF THE FEDERAL TRADE COMMISSION The Federal Trade Commission is an independent agency charged with promoting a competitive marketplace and protecting consumer interests. See 15 U.S.C. 41 et seq. It has substantial experience concerning the balance between antitrust and intellectual property laws. 1 The Commission also exercises primary responsibility over federal antitrust enforcement in the pharmaceutical industry. 1 See, e.g., Federal Trade Commission, The Evolving IP Marketplace: Aligning Patent Notice and Remedies with Competition (2011) (http://www.ftc.gov/reports/antitrust-enforcement-intellectual-property-rightspromoting-innovation-competition-report); U.S. Department of Justice & Federal Trade Commission, Antitrust Enforcement and Intellectual Property Rights: -3-

14 Case: Document: Page: 14 Date Filed: 04/28/2014 STATEMENT OF THE CASE 1. Pharmaceutical Patents, Generic Entry and the Hatch-Waxman Amendments Under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended, 21 U.S.C. 301 et seq., the manufacturer of a new drug must obtain approval from the Food and Drug Administration (FDA) of a new drug application (NDA) before marketing the drug. 21 U.S.C. 355(b). 9 A drug approved under the NDA process is often referred to as a brand-name drug. See generally Caraco, 132 S. Ct. at In 1984, Congress enacted the Hatch-Waxman Amendments, which established how the manufacturer of a generic version of a previously introduced brand-name drug may obtain approval of its product from the FDA using an Abbreviated New Drug Application (ANDA) allowing it more quickly to enter the market. To encourage generic entry as soon as warranted, the Amendments provide certain rights and procedures that apply when a company seeks FDA approval to market a generic product before expiration of the patent(s) claimed to cover the counterpart brand-name drug. In such cases, the generic applicant must certify that the patent in question is invalid or not infringed by the generic product (or both). 9 All references in this brief to Title 21 are to the 2000 version of the United States Code. As used in this brief, drug refers to a drug, as defined in 21 U.S.C. 321(g)(1), that is regulated by the FDA under 21 U.S.C

15 Case: Document: Page: 15 Date Filed: 04/28/2014 This is known as a paragraph-iv certification. 21 U.S.C. 355(j)(2)(A)(vii)(IV); see generally Caraco, 132 S. Ct. at The Hatch-Waxman Amendments encourage (though they do not require) the brand-name manufacturer to respond to a paragraph-iv certification by promptly suing the generic applicant for patent infringement. Such a suit triggers an automatic stay of FDA approval of the ANDA for 30 months. 21 U.S.C. 355(j)(5)(B)(iii). On the generic side, the Hatch-Waxman Amendments reward the first-filer of an ANDA containing a paragraph-iv certification with eligibility to be the exclusive generic provider of the drug for 180 days. See 21 U.S.C. 355(j)(5)(B)(iv). That exclusivity protects the first-filer from price competition from other ANDA filers during the period of exclusivity, and it gives that manufacturer a head start in reaching commercial arrangements with large purchasers. According to the generic pharmaceutical industry s leading trade association, the vast majority of potential profits for a generic drug manufacturer materialize during the 180-day exclusivity period. 10 Significantly, however, the 180-day marketing exclusivity does not preclude the branded-drug company from marketing an AG, which is sold under the brand s NDA as a generic without the 10 Comments of Generic Pharm. Ass n (GPhA) to FTC on Authorized Generic Drug Study 2 (Jun. 27, 2006), -7-

16 Case: Document: Page: 16 Date Filed: 04/28/2014 trademark or brand name. See Teva Pharm. Indus. v. Crawford, 410 F.3d. 51, 54 (D.C. Cir. 2005). 2. The Economics of Generic Entry and Reverse-Payment Agreements Of the approximately $329 billion domestic drug market in 2013, brandname drugs accounted for 14% of total prescriptions for drugs and biologics (which include products such as vaccines) but 71% of total spending. 11 That disparity reflects, inter alia, the monopoly reward that sellers are able to reap from patented drug products. When the first generic version of a given drug comes on the market, it is priced, on average, nearly 15% lower than the brand-name drug. See AG Report at ii-iii. Prices fall further when additional generic competitors enter so that, on average, generic prices end up at an 85% discount compared to what the brandname manufacturer was charging. FTC, Pay-for-Delay: How Drug Company Pay- Offs Cost Consumers Billions 8 (2010), Eventually, the brand- 11 IMS Inst. for Healthcare Informatics, Medicine Use and Shifting Costs of Healthcare: A Review of the Use of Medicines in the United States in 2013, at 30, 40 (Apr. 2014), 53c71ad8c22a/?vgnextoid=c01665b5b VgnVCM ca2RCRD& vgnextchannel=736de5fda vgnvcm ca2rcrd&vgnextfmt= default (requires free registration to download). -8-

17 Case: Document: Page: 17 Date Filed: 04/28/2014 name drug loses on average about 90 percent of its market share (by unit sales) to its generic competitors. Ibid. Market competition from generic pharmaceuticals thus saves consumers many billions of dollars annually. See U.S. Gov t Accountability Off., Report No. GAO R, Savings from Generic Drug Use 9-11 (2012), (discussing studies). Given the significant disparity between monopoly and competitive drug prices, a brand-name manufacturer has strong incentives to induce its would-be generic competitor to forgo competition, and it can offer the generic competitor strong incentives to cooperate. As the diagram below illustrates, while the generic manufacturer will profit if it prevails in paragraph-iv litigation and enters the market, it will gain much less than the brand-name manufacturer stands to lose, and competition shrinks the total profits the two companies will earn in the aggregate. As a result, both the brand-name and generic manufacturers may benefit (at the expense of consumers) if the brand-name manufacturer agrees to share its monopoly profits in exchange for the generic manufacturer s agreement to defer its own entry into the market and thereby keep overall profits at monopoly levels. See, e.g., C. Scott Hemphill, An Aggregate Approach to Antitrust: Using New Data and Rulemaking to Preserve Drug Competition, 109 Colum. L. Rev. 629, (2009). Indeed, such a deal may yield a net benefit to the brand-name manufacturer even if it pays its would-be generic competitors more than they would earn if they -9-

18 Case: Document: Page: 18 Date Filed: 04/28/2014 entered the market. Actavis, 133 S. Ct. at 2235 (citing C. Scott Hemphill, Paying for Delay: Pharmaceutical Patent Settlement as a Regulatory Design Problem, 81 N.Y.U. L. Rev. 1553, 1581 (2006)). These patent settlements can be anticompetitive when the brand-name manufacturer (the patent plaintiff) provides compensation to the generic company (the defendant) in addition to the parties agreement on a date for generic entry. The generic presumably provides some quid pro quo in these circumstances, regardless of whether the brand-name company has paid the generic in cash or in kind. In the absence of another explanation, that quid pro quo may well take the form of the generic company s agreement to stay out of the market for some period in exchange for the branded-drug company s payment. By contrast, if the parties -10-

19 Case: Document: Page: 19 Date Filed: 04/28/2014 agree to a date on which generic entry will be permitted and go no further, the agreement is generally unproblematic because it presumably reflects merely the parties risk-adjusted views of the likely outcome of patent litigation. 3. The Economics of a No-AG Commitment In the earliest reverse-payment arrangements, the branded-drug company typically compensated the generic company in cash for abandoning its patent challenge. After more than a dozen years of antitrust scrutiny, however, parties to such arrangements now use less obvious forms of compensation. 12 An increasingly common mechanism involves the brand-name manufacturer s agreement not to introduce an AG in competition with the generic manufacturer in exchange for the generic s agreement to forestall its own entry. 13 Brand-name companies often introduce AGs to stem the large losses that result from the rapid shift from sales of brand-name drugs to cheaper generic products. See AG Report at 12-14, As the FTC s AG Report describes, a 12 Commentators have noted that after the FTC began challenging cash-only reverse-payment agreements, pharmaceutical companies then turned to other payment arrangements. See, e.g., Michael A. Carrier, Solving the Drug Settlement Problem: The Legislative Approach, 41 Rutgers L.J. 83, 98 (2009). 13 See FTC, Agreements Filed with the Federal Trade Commission Under the Medicare Prescription Drug, Improvement, and Modernization Act (FY 2012) at 2, -11-

20 Case: Document: Page: 20 Date Filed: 04/28/2014 first-filer generic company faces two primary financial effects when it must compete against an AG during the 180-day exclusivity period. First, the AG takes a significant share of generic sales away from the first-filer. Id. at Second, competition between the first-filer generic and the AG drives down generic drug prices. Id. at The FTC s AG Report found that generic wholesale prices average 70 percent of the pre-entry brand-name drug price when the first-filer faces an AG, compared to 80 percent of the brand price when it does not. Id. at iii. Because of these two effects, the presence of authorized generic competition reduces the first-filer generic s revenues [during the 180-day exclusivity period] by 40 to 52 percent, on average. Id.; see also id. at The financial effects of an AG on the first-filer generic are well known in the pharmaceutical industry The report notes that the effects of an AG continue well after first-filer exclusivity expires, as [r]evenues of the first-filer generic manufacturer in the 30 months following exclusivity are between 53 percent and 62 percent lower when facing an [authorized generic]. Id. at iii. 15 According to the trade association for the generic companies: To GPhA s knowledge, the brands have launched an authorized generic during every 180-day generic exclusivity period since September Such products have improperly deprived generic companies of literally hundreds of millions of dollars in sales. Indeed, the first generic to challenge the Paxil patents lost revenues of nearly $400 million on this product alone when the brand launched an authorized generic during the true generic s exclusivity period. Generic Pharmaceutical Association Letter to Senate Special Committee on Aging at 5 (Jul. 27, 2006), -12-

21 Case: Document: Page: 21 Date Filed: 04/28/2014 Accordingly, a generic company enjoys substantial benefits from a No-AG commitment in which the branded-drug company cedes all generic sales to the first generic filer for a period of time. The FTC s study found that, with a no-ag commitment, the first-filer s revenue will approximately double on average, compared to what the first-filer would make if it faced AG competition. AG Report at vi. Given the blockbuster status of Lamictal, GSK s agreement not to launch an AG version of Lamictal tablets during Teva s exclusivity period may have increased Teva s revenues by hundreds of millions of dollars. Teva itself acknowledged these economic realities in the 2008 annual report it filed with the Securities and Exchange Commission. According to Teva, its generic Lamictal tablet product generated substantially increased revenues because it did not face generic competition during the exclusivity period. See Teva Pharm. Indus. Ltd., Annual Report (Form 20-F, at 5 (Feb. 27, 2009), As the FTC s AG Report observed, the industry understands that a No-AG commitment can be a win-win for the brand and generic. For example, one branded-drug company s analysis showed that such an agreement could maximize the combined net present value of both companies products, resulting in their sharing of supracompetitive profits. AG Report at 142 (emphasis added). The -13-

22 Case: Document: Page: 22 Date Filed: 04/28/2014 potential victims in such arrangements are consumers, who end up paying far more than they otherwise would. 4. The Supreme Court s Decision in FTC v. Actavis and the Current Litigation The plaintiffs complaint in this case alleges that GSK induced Teva to stay out of the market for a defined period by promising that, once Teva finally did enter, GSK would not compete against Teva with authorized-generic versions of Lamictal. In 2012, the district court granted GSK s and Teva s motion to dismiss that complaint. The court declined to apply this Court s analysis of reversepayment settlements in In re K-Dur Antitrust Litigation, 686 F.3d 197, 218 (2012), by incorrectly limiting the broad principles articulated in that ruling to cases involving the payment of cash. Plaintiffs appealed to this Court, which stayed the proceeding pending the U.S. Supreme Court s ruling in FTC v. Actavis. In Actavis, the Supreme Court held that reverse-payment patent settlements can violate the antitrust laws and should be evaluated under the rule of reason. 133 S. Ct. at The FTC s complaint in that case alleged that the brand-name manufacturer of the testosterone replacement drug AndroGel had agreed to pay two generic companies in exchange for their agreements to stay off the market for six years. The district court dismissed the complaint, and the Eleventh Circuit affirmed. It reasoned that the agreements were immune from antitrust attack if their anticompetitive effects were all within the scope of the exclusionary -14-

23 Case: Document: Page: 23 Date Filed: 04/28/2014 potential of the patent. FTC v. Watson Pharm., Inc., 677 F.3d 1298, 1312 (11 th Cir. 2012). The Supreme Court reversed and, in the process, rejected this so-called scope-of-the-patent test and its resulting immunity for settlement agreements that do not exceed the exclusionary potential of the patent. 133 S. Ct. at The Court explained that its longstanding approach to assessing whether agreements between a patentee and potential competitors violate the antitrust laws considers traditional antitrust factors such as likely anticompetitive effects, redeeming virtues, market power, and potentially offsetting legal considerations present in the circumstances, such as here those related to patents. Id. at Shortly after the Supreme Court issued its decision, this Court remanded this case for further proceedings. Plaintiffs moved for reconsideration of the district court s original decision granting the motion to dismiss. The court rejected plaintiffs motion and reaffirmed its original decision. It stated that the Actavis opinions reek with discussion of payment of money (slip op. at 13) and concluded that the principles of Actavis apply only where there is a payment of money. Id. at 15. The district court also opined that, even if the rule of reason applied, this agreement would likely survive scrutiny. Id. at

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